摘要
目的评价改良免疫层析法在泌尿生殖道沙眼衣原体(CT)感染的检测质量,探讨其临床应用价值。方法运用改良免疫层析法试剂盒(简称chemtrue-CT)对3家医院的261例性病门诊和健康体检者进行检测,同时以聚合酶链反应(PCR)试剂盒(简称PCR-CT)检测作为标准,分析chemtrue-CT的检测性能。结果chemtrue-CT阳性率21.8%,PCR-CT阳性率28.4%,PCR-CT阳性率高于chemtrue-CT(P<0.01)。chemtrue-CT敏感性和特异性分别是75.7%和99.5%,总体符合率92.7%。其中男性组2种方法总符合率88.8%,阳性率差异有统计学意义(P<0.01);女性组2种方法总符合率为97.4%,阳性率差异无统计学意义(P>0.05);女性中高危人群和健康人群2种试剂检测总符合率分别为96.8%和98.2%。结论改良衣原体免疫层析法与PCR之间的检测差异正在缩小,尤其对女性人群的检测性能接近PCR。
Objective To evaluate the performance of an improved immuno-chromatographic assay for the detection of chlamydia trachomatis( CT) in genitourinary tract infection, and then to assess the significance of clinical application. Methods A total of 261 patients from sexually transmited infection clinics and healthy subjects in 3hospitals of Shanghai were enrolled and determined by an improved immuno-chromatographic assay kit( chemtrue-CT).The polymerase chain reaction( PCR) kit( PCR-CT) as a reference standard was used to analyze the performance of chemtrue-CT. Results The total positive rate of PCR-CT( 28. 4%) was higher than that of chemtrue-CT( 21. 8%,P < 0. 01). The sensitivity and specificity of chemtrue-CT were 75. 7% and 99. 5%,respectively. The overall coincidence rate between the 2 assays was 92. 7% with male group' s coincidence rate 88. 8%( P < 0. 01) and female group's coincidence rate 97. 4%( P > 0. 05). The 2 assay results were similar with an overall coincidence rate of96. 8% and 98. 2% in female group. Conclusions The performance difference between chemtrue-CT and PCR-CT is narrowing. Particularly for female group,chemtrue-CT shows acceptable performance in comparison with PCR-CT.
出处
《检验医学》
CAS
2014年第12期1226-1229,共4页
Laboratory Medicine
基金
上海市自然科学基金项目(06ZR14068)
关键词
免疫层析法
聚合酶链反应
方法评价
衣原体
Immuno-chromatographic assay
Polymerase chain reaction
Methodology evaluation
Chlamydia
